Micrograph of cholangiocarcinoma. Credit: Nephron / Wikimedia.

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).

KIN-3248 is indicated to treat CCA harbouring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations in people who previously received a minimum of one systemic therapy.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The irreversible, small molecule investigational pan-FGFR inhibitor KIN-3248 has been designed to target cancer-associated alterations in FGFR2 and FGFR3 genes.

It aims to address primary driver-alteration and clinically observed and predicted FGFR 2/3 mutations that drive resistance to current FGFR2- and FGFR3-targeted therapies in urothelial carcinoma (UC) and intrahepatic cholangiocarcinoma (ICC).

KIN-3248 showed inhibitory activity in a broad range of clinically relevant mutations that drive acquired resistance and primary disease to other FGFR inhibitors in preclinical trials.

The company is now evaluating KN-4802 in an ongoing open-label, multi-centre, two-part clinical trial.

The trial has been designed to assess KIN-3248’s tolerability, preliminary efficacy, safety and pharmacokinetics in adult patients with advanced tumours harbouring FGFR2 and/or FGFR3 gene alterations.

Currently, it is enrolling participants across several sites in Taiwan and the US, with additional sites anticipated to be added globally.

The trial will determine KIN-3248’s recommended dose and schedule it for further assessment in FGFR2 and/or FGFR3 gene alteration-driven cancer patients in dose escalation (Part A).

In dose expansion (Part B), KIN-3248’s efficacy and safety will be evaluated at the recommended dose and scheduled in FGFR inhibitor naïve and FGFR inhibitor pre-treated subjects with FGFR2 and/or FGFR3 gene alterations including UC, ICC, and other metastatic or advanced solid tumours.

Kinnate Biopharma expects to receive initial dose escalation data in the second half of this year.